The race is on for a coronavirus vaccine among military, government and private labs
Military and government researchers are working on separate vaccines for the coronavirus – but the successful product will still take a year or more to reach the public, officials said Thursday.
As one effort at the National Institutes of Health makes its way to human trials, the Army is experimenting with a potential vaccine on mice, several Army scientists told reporters.
Army researchers working on a potential vaccine have obtained a coronavirus sample from a patient in Washington state and have focused their effort on the “spokes” of the fast-spreading pathogen, hoping to develop a way for humans to block it from entering humans and attaching to cells.
“From the first day that the sequences of this virus were published, we were working on the vaccine,” Dr. Kayvon Modjarrad, director of emerging infectious diseases at the Walter Reed Army Institute of Research, said.
The coronavirus sample that the Defense Department obtained to develop a vaccine came from Washington state, he said. “It came from a U.S. patient - Washington state.”
Still, no vaccine would be ready in time to address the current outbreak. The goal would be to have potential vaccines vetted in time for next winter, in case there is a second wave of coronavirus, the Army scientists said.
The military effort comes as another potential vaccine, produced by scientists at Moderna and the National Institute of Allergy and Infectious Diseases (NIAID), received authorization for clinical trials on Monday by the Food and Drug Administration.
The first phase of trial for that vaccine will be held in Washington state – where 11 deaths have been linked to the coronavirus – at the Kaiser Permanente Washington Health Research Institute in Seattle, a NIAID-supported evaluation facility, a NIAID official told McClatchy.
“Participants have not yet received the vaccine and the date for the first vaccination is not yet firm,” the official said. “This is dependent on multiple factors, including participant availability.”
The phase one experiment aims to enroll 45 “healthy adults” as participants in Washington state, according to a description of the clinical trial.
NIAID’s Viral Pathogenesis Laboratory, which focuses on vaccine development for viral diseases, received a visit from President Donald Trump this week. Its scientists told him they expect their experimental vaccine will be ready for human trials within a six-week period.
That competitive medical race for a vaccine has provided Trump administration officials with confidence that one will emerge in due course.
But the timeline for its availability remains fixed at a year to a year-and-a-half from the point of its discovery, based on established medical guidelines to protect the public.
Dr. Anthony Fauci, the head of NIAID and a member of Trump’s coronavirus task force, told reporters this week that government scientists are “going more quickly than we’ve ever done” through trials for a vaccine.
“If you’re looking at what’s going to be available, the one dictum that you always know in medicine is: First, do no harm,” Fauci said. “We’ve got to make sure that if we’re going to protect the American people, if we’re going to be giving them a vaccine to otherwise healthy people to protect them, we’ve got to make sure we have a vaccine that is safe and that is proven to be effective.”
Fauci and Vice President Mike Pence, who is leading the task force, have repeatedly reminded the public that a vaccine will not be available for over a year.
“We emphasized to the president that since we’ll be giving the vaccine to normal, healthy people, that safety is very important and you really need to know that it actually works,” Fauci said alongside Trump on Tuesday, emphasizing the timeline, after visiting the NIAID laboratory.
Their emphasis on the extended timeline during an acute public health crisis provided Trump, faced with turbulent financial markets and a fast-approaching election, with a clear reminder that a quick fix to the coronavirus is not on the table.
That has been a source of frustration for the president, who on Monday, at a roundtable with private sector pharmaceutical companies, had expressed hope that a vaccine could be produced “over the next few months.”
The pharmaceutical executives, who had been summoned to the White House to discuss prescription drug pricing, instead took turns promoting their ability to produce massive quantities of a coronavirus vaccine once one completes the trial process.
One pharmaceutical executive explained to Trump why an approval cannot be rushed.
“Vaccines have to be tested because there’s precedence for vaccines to actually make diseases worse,” Lenny Schleifer, founder and CEO of Regeneron, said in the Cabinet Room roundtable. “And you really don’t want to make it – you don’t want to rush and make it – you don’t want to rush and treat a million people and find out you’re making 900,000 of them worse.”
“That’s a good idea,” Trump replied.
Since then, Trump has emphasized that therapeutics – treatment drugs used to improve the condition of individuals who are already ill – can be prepared in a shorter period of time.
There is a race to produce those drugs, as well.
Pfizer, GlaxoSmithKline and Sanofi have said they are working on both treatments and vaccines of their own. Overseas, Chinese and Japanese researchers are experimenting with the use of serums – injecting coronavirus-infected patients with blood plasma from recovered patients – as a potential antidote, with encouraging results, according to the World Health Organization.
One potential antiviral treatment, called remdesivir and produced by Gilead Sciences, began being used in experimental trials on adults already infected with COVID-19 in Nebraska on Tuesday. The same drug is also undergoing tests in China, where the coronavirus outbreak began.
Investigative scientists in the Nebraska experiment “will compare participant outcomes on day 15 in both the remdesivir group and the placebo group to see if the investigational drug increased clinical benefit compared to placebo,” the National Institutes of Health, of which NIAID is a part, said in a statement. “Outcomes are scored on a seven-point scale ranging from fully recovered to death.”
At a congressional budget hearing Thursday on the military’s health system, Thomas McCaffery, assistant secretary of defense for health affairs, told lawmakers that the Army’s coronavirus vaccine is not yet close to a solution.
“I believe clinical trials for that will not be for another few months,” McCaffery told the House Appropriations Committee on Defense. “In terms of a final, determined, FDA approved vaccine, likely we are looking at 16, 18 to 24 months.”
McCaffery said the Defense Department’s research on a potential antiviral therapy, a medicine that could be effective in helping those infected with coronavirus get well, may be closer to release.
“We may be closer there in terms of having something that can be usable, it’s actually in clinical trials right now,” he said.
Modjarrad, of the Walter Reed Army Institute of Research, said that Army researchers will go slow in their work on a vaccine.
If there is not a bad reaction to the vaccine in mice, they will test on larger animals, then human volunteers, he said. An initial round of tests with human subjects, which could include both military and civilian volunteers, would involve a few dozen people before the study would be expanded, he said.
“Think of this as the virus, my fist, you know it’s a sphere, and it’s got little spokes coming off of it, that makes it the corona,” Modjarrad said at the Pentagon, lifting his arm. “So almost all the vaccine candidates out there are focused on that … what we call ‘the spike,’ the spike protein,” he said.
“And there are different parts of the spike that mediate the attachment of the virus and the entry of the virus into ourselves. So if you block that attachment, if you get a vaccine that trains and educates your immune system to recognize that part of the virus that attaches to yourselves and blocks it, that’s going to be a good vaccine, so that’s why everybody’s focused on that,” Modjarrad said.
Updates with 11 deaths now in Washington state.
This story was originally published March 5, 2020 at 6:18 PM.
